ENGERIX-B VACCINE 10 mcg0.5 ml

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

HEPATITIS B SURFACE ANTIGEN PROTEIN (YEAST)

Commercializzato da:

GLAXOSMITHKLINE PTE LTD

Codice ATC:

J07BC01

Dosaggio:

10 mcg/0.5 ml

Forma farmaceutica:

INJECTION

Composizione:

HEPATITIS B SURFACE ANTIGEN PROTEIN (YEAST) 10 mcg/0.5 ml

Via di somministrazione:

INTRAMUSCULAR

Tipo di ricetta:

Prescription Only

Prodotto da:

GlaxoSmithKline Biologicals S.A.

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

1988-07-04

Foglio illustrativo

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_ _
_ENGERIX™-B _
HEPATITIS B (RDNA) VACCINE (ADSORBED) 

QUALITATIVE AND QUANTITATIVE COMPOSITION

10 µg dose vaccine 

1 dose (0.5 ml) contains: 

Hepatitis B surface antigen
 1, 2
 10 
micrograms 

1
Adsorbed on aluminium hydroxide, hydrated 

       Total: 0.25 milligrams Al
3+

2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology 

20 µg dose vaccine 

1 dose (1 ml) contains: 

Hepatitis B surface antigen
1, 2
 20 
micrograms 

1
Adsorbed on aluminium hydroxide, hydrated 
Total: 0.50 milligrams Al
3+

2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology 

The vaccine is highly purified, and exceeds the WHO requirements for
recombinant hepatitis 
B vaccines. No substances of human origin are used in its
manufacture. 

PHARMACEUTICAL FORM

Suspension for injection. 
Turbid white suspension. 
Upon storage, a fine white deposit with a clear colourless
supernatant may be observed. 

CLINICAL PARTICULARS

INDICATIONS

ENGERIX™-B is indicated for active immunisation against HBV
infection caused by all known 
subtypes in subjects of all ages considered at risk of exposure to
HBV. It can be expected that 
hepatitis D will also be prevented by immunisation
with ENGERIX™-B as hepatitis D (caused 
by the delta agent) does not occur in the absence of hepatitis B
infection. 
Immunisation against hepatitis B is expected in the long term to
reduce not only the incidence 
of this disease, but also its chronic complications such as chronic
active hepatitis B and 
hepatitis B associated cirrhosis. 
In areas of LOW PREVALENCE of hepatitis B, immunisation is
particularly recommended for 
those belonging to groups identified at increased risk of infection
(see below), however, 
universal immunisation of all infants and adolescents will contribute
to the control of hepatitis 
B on a population basis. 
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In areas of�

Scheda tecnica

_1 _
_ _
ENGERIX-B
HEPATITIS B (RDNA) VACCINE (ADSORBED)
SUSPENSION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 µg dose vaccine
1 dose (0.5 ml) contains:
Hepatitis B surface antigen
1, 2
10 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
Total: 0.25 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
20 µg dose vaccine
1 dose (1 ml) contains:
Hepatitis B surface antigen
1, 2
20 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
Total: 0.50 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
The vaccine is highly purified, and exceeds the WHO requirements for
recombinant hepatitis
B vaccines. No substances of human origin are used in its manufacture.
Turbid white suspension.
Upon storage, a fine white deposit with a clear colourless supernatant
may be observed.
CLINICAL INFORMATION
INDICATIONS
Engerix-B is indicated for active immunisation against hepatitis B
virus (HBV) infection
caused by all known subtypes in subjects of all ages considered at
risk of exposure to HBV. It
can be expected that hepatitis D will also be prevented by
immunisation with Engerix-B as
hepatitis D (caused by the delta agent) does not occur in the absence
of hepatitis B infection.
Immunisation against hepatitis B is expected in the long-term to
reduce not only the incidence
of this disease, but also its chronic complications such as chronic
active hepatitis B and
hepatitis B associated cirrhosis.
In areas of LOW PREVALENCE of hepatitis B, immunisation is
particularly recommended for
those belonging to groups identified at increased risk of infection
(see below), however,
universal immunisation of all infants and adolescents will contribute
to the control of hepatitis
B on a population basis.
In areas of INTERMEDIATE AND HIGH PREVALENCE of hepatitis B, with most
of the population at
risk of acquiring the HBV, the best strategy is to provide universal
immunisation of neonates,
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infants, children and adolesce